Suppliers and packagers for generic pharmaceutical drug: netupitant; palonosetron hydrochloride

netupitant; palonosetron hydrochloride

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718	NDA	Helsinn Therapeutics (U.S.), Inc.	69639-101-01	1 BLISTER PACK in 1 CARTON (69639-101-01) / 1 CAPSULE in 1 BLISTER PACK	2014-10-13
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718	NDA	Helsinn Therapeutics (U.S.), Inc.	69639-101-04	2 BLISTER PACK in 1 CARTON (69639-101-04) / 2 CAPSULE in 1 BLISTER PACK	2014-10-13

Suppliers for the Pharmaceutical Drugs: Netupitant and Palonosetron Hydrochloride

Last updated: July 30, 2025

Introduction

Netupitant and palonosetron hydrochloride are critical components used in combination therapies for the prevention of chemotherapy-induced nausea and vomiting (CINV). These drugs are frequently supplied as a fixed-dose combination under the brand name Akynzeo. The global demand for these medications is driven primarily by the rising incidence of cancer, expanding oncology treatments, and increasing recognition of advanced antiemetic regimens. Identifying reliable suppliers and understanding the supply landscape is crucial for pharmaceutical companies, healthcare providers, and distributors seeking consistent quality and supply chain stability. This article provides a comprehensive overview of suppliers specializing in netupitant and palonosetron hydrochloride.

Overview of Netupitant and Palonosetron Hydrochloride

Netupitant

Netupitant is a selective neurokinin-1 (NK1) receptor antagonist, primarily used to inhibit substance P-mediated pathways involved in nausea and vomiting. It boasts a long half-life, making it suitable for single-dose administration during chemotherapy cycles.

Palonosetron Hydrochloride

Palonosetron hydrochloride is a potent 5-HT3 receptor antagonist with a unique binding affinity and extended half-life, providing prolonged antiemetic effects. It is often combined with netupitant for comprehensive CINV prevention.

Global Supplier Landscape

Manufacturers and Proprietary Rights

Several pharmaceutical companies produce netupitant and palonosetron hydrochloride, either as proprietary medications or as active pharmaceutical ingredients (APIs). Manufacturers may be broadly categorized into original innovators, generics producers, and contract manufacturing organizations (CMOs). The supply chain involves sourcing high-quality APIs, advanced formulation, and distribution channels.

Key Suppliers of Netupitant

• Takeda Pharmaceutical Company
  Takeda holds exclusive rights for the marketing and distribution of Akynzeo in numerous jurisdictions, including the United States and Europe. The company manufactures netupitant as part of its integrated manufacturing process, ensuring high standards of quality and supply security. Takeda’s global manufacturing facilities produce APIs and finished products adhering to stringent regulatory standards (FDA, EMA).

• Indigenous and Emerging API Manufacturers
  Several Chinese and Indian API producers have entered the netupitant supply chain, often supplying to generic drug manufacturers under licensing agreements or as raw materials for further formulation. Notable among these are Jiangsu Hengrui Medicine and Zhejiang Huahai Pharmaceutical, which possess robust API manufacturing capabilities.

Suppliers of Palonosetron Hydrochloride

• Sandoz (Novartis)
  Sandoz, a division of Novartis, markets palonosetron as part of its antiemetic portfolio. The company manufactures the API and provides finished formulations through its global manufacturing network.

• Teva Pharmaceutical Industries Ltd.
  Teva supplies palonosetron hydrochloride as both an API and a finished drug product, with manufacturing facilities compliant with Good Manufacturing Practices (GMP), primarily serving the generic market.

• Shandong Luoxin Pharmaceutical Group
  A significant Chinese API manufacturer, offering palonosetron hydrochloride. The company has achieved regulatory approvals in China and is expanding into international markets.

• Zhejiang Hisun Pharmaceutical Co., Ltd.
  An established producer of injectable drugs and APIs, including palonosetron hydrochloride, with certifications enabling exports and licensing agreements.

Contract Manufacturing Organizations (CMOs)

• Several CMOs, such as Baxter and Fresenius Kabi, provide custom manufacturing for both APIs and finished dosage forms, often sourcing APIs from top suppliers and ensuring regulatory compliance.

Quality and Regulatory Standards

Suppliers operating in this domain adhere to strict quality management systems, including GMP, ISO certifications, and consistent batch testing. Regulatory approval by agencies like the FDA, EMA, or China's NMPA (National Medical Products Administration) is essential for global distribution.

Manufacturers that supply APIs often undergo rigorous audits and must establish stability, purity, and bioavailability standards consistent with international guidelines.

Supply Chain Challenges and Considerations

• Regulatory Compliance: Ensuring API suppliers meet global regulatory standards is crucial for risk mitigation.
• Manufacturing Capacity: High global demand necessitates diversified sourcing to prevent shortages.
• Intellectual Property (IP): Licensing agreements are often pivotal due to patent protections surrounding proprietary formulations.
• Geopolitical Factors: Trade tensions and export restrictions may impact supply chain stability, especially for Chinese and Indian API producers.

Emerging Trends in Supplier Selection

• Vertical Integration: Larger pharmaceutical companies increasingly integrate API manufacturing to secure supply and quality control.
• Strategic Alliances and Licensing: Licensing agreements enable access to high-quality APIs while expanding manufacturing capacity.
• Digital Tracking and Quality Assurance: Supply chain traceability ensures compliance and batch authenticity, maintaining quality standards.

Conclusion

The supply landscape for netupitant and palonosetron hydrochloride comprises a mix of proprietary manufacturers, generic API producers, and CMOs. Takeda remains the primary supplier for netupitant, particularly through its flagship product Akynzeo. Palonosetron hydrochloride's supply is more diversified, with key players like Sandoz, Teva, and Chinese manufacturers providing both APIs and formulations. Ensuring resistance to supply disruptions involves sourcing from multiple suppliers, verifying regulatory compliance, and maintaining stringent quality standards.

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Key Takeaways

• Takeda is the principal supplier of netupitant, primarily through its proprietary product Akynzeo.
• Palonosetron hydrochloride is supplied by multiple companies, including Sandoz, Teva, and several Chinese API manufacturers.
• Rigorous adherence to GMP and international regulatory standards is essential for suppliers in this market.
• Diversification of suppliers mitigates risks associated with manufacturing disruptions, trade restrictions, or quality issues.
• Strategic licensing and alliances are common to expand manufacturing capacity and ensure supply stability.

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FAQs

1. Who are the leading global suppliers for netupitant?
Takeda Pharmaceutical is the primary global supplier of netupitant, especially through its marketed product Akynzeo. Other API manufacturers, mainly in China and India, supply raw materials to generic drug producers.

2. Which companies manufacture palonosetron hydrochloride?
Major companies include Sandoz (Novartis), Teva Pharmaceuticals, Zhaotong Hisun Pharmaceutical, and Shandong Luoxin Pharmaceutical Group, all producing both APIs and finished products.

3. How do regulatory standards impact supplier selection?
Suppliers must comply with GMP, ISO, and local regulatory standards (FDA, EMA, NMPA). Non-compliance risks supply rejection, product recalls, and legal ramifications.

4. Are there risks associated with Chinese API manufacturers for these drugs?
Yes, while Chinese manufacturers often offer cost advantages and high capacity, risks include variability in quality control, regulatory acceptance, and supply chain security. Proper qualification and audits mitigate these risks.

5. What trends are influencing the supplier landscape for these drugs?
Vertical integration, strategic licensing, and digital supply chain management are trending, aimed at ensuring consistent supply, regulatory compliance, and quality assurance.

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Sources:

1. [Takeda’s official product portfolio and licensing agreements.]
2. [FDA drug approvals and regulatory filings for Akynzeo.]
3. [Industry reports on Chinese API manufacturers.]
4. [Pharmaceutical industry insights on GMP and quality standards.]
5. [Market analysis reports on antiemetics and API supply chains.]